Is India ready for the biopharma revolution?

On 23 July, Envirotainer announced its sixth station in India, at Navi Mumbai. The airport had handled its first international cargo only eight days earlier, 1,789 kg of fruit and vegetables flown to Abu Dhabi in the belly of a passenger flight. Dedicated freighters had yet to arrive. The company chose to build first and wait for the volumes to follow.

That is a bet on where Indian pharma is heading. For decades, India has been the pharmacy of the world. It makes generic tablets and vaccines in huge numbers at low cost. The next chapter is harder. It involves biologics, biosimilars and advanced therapies. These medicines are difficult to make and fragile to move.

The government has placed a large bet of its own. Biopharma SHAKTI, announced in the Union Budget 2026-27, commits ₹100 billion over five years to build a domestic biologics ecosystem. Money is only one part of the answer. The bigger question is whether the whole chain is ready. That chain covers manufacturing, research, regulation, talent and logistics.

Biologics need more than factories. They need reliable raw materials, trial sites, regulators who can judge complex products, skilled scientists and a cold chain that never breaks. Every link has to hold. India’s strengths are real. The weak points sit in the joins between them.

Why the world is shifting to biologics
A conventional drug is made through chemical synthesis. The molecule is small and stable. A biologic is grown in living cells. The molecule is large and complex, often hundreds of times bigger than a chemical drug. Insulin, cancer antibodies and vaccines are all biologics. A biosimilar is a follow-on version of an original biologic, launched once the patent runs out. Biosimilars are typically 30 to 50% cheaper than the originals.

The reason is disease. India’s disease burden is shifting towards diabetes, cancer and autoimmune conditions. Non-communicable diseases now cause more than half of all deaths in the country, according to the Economic Survey 2025-26. Biologics sit at the centre of treatment for many of these conditions. They are also costly, and access is limited.

Rajesh Shetty, Supply Chain Lead at Roche, says access is the biggest challenge for advanced biologics in India. He credits recent cuts in GST and customs duty with helping, but says more government spending in these disease areas is still needed. He wants more of these drugs to come under public supply channels such as the Central Government Health Scheme (CGHS) and Jan Aushadhi.

India’s starting position is a paradox. Government data show the country ranks third in the world for pharmaceutical output by volume, but eleventh by value. Generics built that volume. Biologics are how India could climb the value ladder.

Biopharma SHAKTI is designed to help with that climb. The strategy adds three new National Institutes of Pharmaceutical Education and Research (NIPERs) and upgrades seven existing ones. It plans a network of over 1,000 accredited clinical trial sites. It also strengthens the Central Drugs Standard Control Organisation (CDSCO) with a dedicated scientific review cadre. The wider aim is a 5% share of the global biopharmaceutical market. It builds on earlier efforts such as the National Biopharma Mission, launched in 2017.

Strong on volume, thin on original research
India already makes biosimilars. That is a genuine strength. Shetty says the ecosystem needs to go further. R&D spending by most Indian companies is far lower than that of global giants, he says. Most focus on biosimilars, which follow an original patented product. The work is still technology intensive, and he puts development time at three to five years. Building patented drugs of their own needs significant investment beyond that.

There are early signs of change. Wockhardt’s antibiotic Zaynich won approval from the US Food and Drug Administration on 30 May and has been cleared by CDSCO in India. It is described as the first fully indigenous new chemical entity to win that approval. Zaynich is an antibiotic, not a biologic. Even so, it shows what a home-grown discovery effort can achieve. Shetty says the same kind of effort now has to happen in biologics.

Sheshagiri Koppal, Deputy General Manager for Direct Procurement at Olon, sees the same gap from the manufacturing side. India is still largely seen as a generic supplier, he says. It needs to build an image as a supplier of high-value products. He believes the country remains behind China and Europe in some areas.

Complex molecules add a second problem. Koppal says only a small number of suppliers may be able to make them, and some have limited R&D strength. The industry needs to improve its research capability, he says. Better R&D would help companies develop new products and cut the cost of existing ones. The number of products is also rising, and the industry must keep pace with the market.

Antibody-drug conjugates show where demand is heading. These link an antibody to a potent drug to hit cancer cells. Koppal says many companies are entering the segment worldwide, and government involvement comes at an important time.

Talent sits behind all of this. The new and upgraded NIPERs are meant to produce specialists in biopharma research, manufacturing and regulation. Koppal wants regular talks between the government and industry on talent development. He also wants shared common services, such as effluent treatment and analytical labs, so that companies split the cost instead of each building its own.

The upstream problem: Raw materials
A biologic is only as secure as its inputs. Hanoz Tarapore, Country Supply Chain Head for ASEAN, Korea, Australia and New Zealand at QuidelOrtho, says India must cut its dependence on imported active pharmaceutical ingredients, or APIs, and raw materials. He wants a local supplier ecosystem, built along the lines of the automotive industry.

The key would be to reduce the dependence on API and raw material imports
Hanoz Tarapore, QuidelOrtho

He also draws a lesson from global disruptions. Companies should avoid single-source suppliers, he says. They should invest in diversification so that business continuity plans hold when something breaks.

Koppal agrees on domestic sourcing. Olon’s first preference is local supply, he says. For intermediates, key starting materials and specialty molecules, India is still developing, though it is making gradual progress. His advice is practical. Work with domestic sources to develop a material locally, and keep the existing supplier in parallel.

Capability of this kind does exist in India. Olon’s Mahad site in Maharashtra combines fermentation with chemical synthesis and has added a high-containment line for potent compounds. The challenge is to spread that depth across the many materials biopharma needs.

Regulation and trials: What innovators want
Regulators and trial sites decide how fast a new therapy reaches patients. SHAKTI targets both. The CDSCO review cadre is meant to bring approval timelines closer to global standards. The 1,000-site network is meant to widen trial coverage across the country.

Shetty says trial approvals are already getting faster, especially for patented products. India is slowly regaining its place as a trial hub, he adds. Global innovators still want more clarity before they invest fully. Pricing policy is one concern. He says pricing controls need clearer rules so that multinationals feel able to bring advanced technology into India. He also raises concerns about how consistently patents are respected.

Diagnostics ties into all of this. Khyati Desai, Senior Manager for Global Trade Compliance at Thermo Fisher Scientific spoke to Indian Transport and Logistics News in her individual capacity, not representing the company’s views and explained, “Diagnostics and biologics increasingly function as one supply chain rather than two separate ones.” Every trial site will depend on diagnostic steps upstream, she notes. These include patient identification, companion testing and response monitoring. She expects diagnostics volumes to grow alongside biologics and to move through the same cold chain lanes.

Diagnostic reagents and assay kits carry the same sensitivity as the biologics they support
Khyati Desai, Thermo Fisher Scientific

Desai also notes that alignment with international regulatory frameworks is generally linked to better market access. She adds that many observers expect readiness for revised good distribution standards to stay uneven for some time, particularly among smaller manufacturers.

Funding is another test. Biopharma SHAKTI's ₹10,000 crore is spread over five years, an average of about ₹2,000 crore a year, against three new institutes, seven upgrades, more than 1,000 trial sites and a strengthened CDSCO. Whether that stretches far enough will depend on how the money is phased and where it lands first. Koppal's caution about the gap between announcement and delivery applies here as much as anywhere.

Logistics: The real stress test
Biologics change what logistics has to do. Kuntal Baveja, Regional President Asia Pacific at Envirotainer, says tablets and many oral medicines can tolerate wide temperature ranges. Biologics, vaccines, biosimilars and advanced therapies cannot. Small deviations can affect their efficacy.

Air cargo carries the weight. It is less than 1% of India’s trade by volume but over 30% by value. Government data show India handled about 3.72 million tonnes of air cargo in 2024-25. The government’s target is 10 million tonnes a year by 2030. Pharma is among the key growth drivers, according to Yuvraj Sharma, Head of Sales and Marketing at Kuehne+Nagel India, Sri Lanka and Maldives.

Strong at the gateways, uneven beyond them
Sharma says, “India’s pharma supply chains have made significant progress in supporting the tighter temperature, handling and visibility requirements of biologics and advanced therapies.” He points to Hyderabad as a key hub for both manufacturing and healthcare logistics. The city accounts for roughly a third of India’s pharmaceutical production, by some industry estimates. Kuehne+Nagel runs a healthcare facility there and a gateway facility in Bengaluru.

Specialised packaging, real-time monitoring and end-to-end visibility are now fundamental requirements for temperature-sensitive pharmaceutical logistics
Yuvraj Sharma, Kuehne+Nagel 

Heike Wörner, Head of Business Development at Lufthansa Cargo, agrees on the hubs but adds a caveat. “At major gateways, strong capabilities are already available, but the level of infrastructure and cold-chain coverage is not yet uniform across the country,” she says.

Tarapore sees the same gap on the ground. Pharma-grade cold chain distribution, especially in the last mile, is “concentrated with very few formal LSPs,” he says, using the industry term for logistics service providers. He compares India with Australia, another vast country, where certified cold chain facilities operate in every major city. India needs the same in its Tier 1 and Tier 2 cities, he argues. He also wants healthcare and cold chain hubs and free trade zones like those in Singapore and Malaysia, which make a country a regional distribution base for multinationals.

Shetty gives the shipper’s view. Cold chain infrastructure is growing quickly, he says, but “it is still not sufficient for large scale.” Roche protects its own products with due diligence before it onboards any vendor, training for distributors and logistics providers, and real-time shipment monitoring.

Diagnostics face the same test. Desai says reagents and assay kits are as sensitive as the biologics they support. Published market analyses suggest the validated warehousing and transport built for pharma exports has not been matched at the same scale for diagnostics, she says.

Handovers are where shipments fail
The greater risk is not necessarily at the hubs. Baveja says, “Temperature-sensitive shipments are often most vulnerable during transportation between facilities, logistics partners or transport modes.” Handover points introduce risk when processes, training or infrastructure are not aligned, he adds.

Wörner describes the same problem as a chain of interfaces. A shipment passes through acceptance, ground handling, airport processes, flights, transfers and final delivery. Consistency at every interface matters, she says. She wants shorter, more predictable transit and dwell times and faster customs processes. Capacity alone does not solve the problem.

Capacity is important, but additional capacity alone is not sufficient for complex pharmaceutical supply chains
Heike Wörner, Lufthansa Cargo

Shippers want visibility. Koppal says logistics providers should offer real-time shipment tracking, a single point of contact and a clear escalation matrix. They should also keep costs stable over a longer period, he adds, because cost swings feed into the price of the final product.

Baveja sees a change in how manufacturers plan. The shift towards biologics is pushing Indian companies to think about packaging and transport much earlier in product development, he says. Logistics is becoming a strategic consideration rather than only an operational one. He also sees greater demand for precise temperature control, shipment monitoring and data analytics.

Validated solutions matter here. Baveja calls them essential because global supply chains involve long transit times, multiple handovers and very different environmental conditions. They give manufacturers the confidence to reach distant markets, he says.

Packaging carries its own trade-off. Shetty says thermal protection comes first for Roche, then sustainability. Cost comes later, and he admits advanced packaging is not yet cost efficient. Roche reuses packs many times to recover the expense over time.

Build ahead or build alongside?
Baveja argues for building capacity before demand arrives. Envirotainer’s Navi Mumbai station doubled the capacity of its existing Mumbai operation, the company said. Dedicated freighter flights at the airport began on 1 August, 2026. Wörner takes a more measured line. Infrastructure needs to scale alongside market growth, she says.

Wörner adds a useful reminder. Logistics is one factor among several when companies choose where to manufacture. Market access, regulation, skilled labour and the wider industrial ecosystem count too. Her job, she says, is to make sure logistics does not become a bottleneck.

Both views matter for investors. Cold rooms, terminals and certified warehouses take time to build. If demand arrives first, shipments will move through the gaps. Government targets would take air cargo from about 3.7 million tonnes to 10 million tonnes by 2030. Pharma will need cold capacity that grows in step.

The biggest gaps
Put together, the voices point to four gaps. The first is consistency in the cold chain beyond the main hubs and across every handover. The second is upstream materials, from APIs to key starting materials. The third is depth in R&D and confidence among global innovators on pricing and patents. The fourth is execution and funding. Each gap is fixable, but none can be fixed by one party alone.

Koppal puts the last point plainly. He warns that “announcing an initiative is one thing, while implementing it effectively is another.” He wants the government and industry to meet regularly so that hurdles are found early. Timely execution, he says, will let the industry see results faster.

Read pillar by pillar, the picture is mixed. Manufacturing capability is strong in volume and still building in complexity. Regulation is being strengthened, but the results are not yet visible. Talent and R&D need the longest lead time. Logistics is strong at the hubs and uneven across the network.

What it means for logistics providers
For forwarders, airlines and cold chain providers, the message is practical. Certified capacity is needed in Tier 1 and Tier 2 cities, not only at the gateways. Handover training and aligned processes matter as much as equipment. Shippers want real-time tracking, one point of contact and a clear escalation path. Providers that can offer those three things will be better placed as biologics volumes grow.

So, is India ready?
In parts, yes. Manufacturing strength is real. Policy intent is clear. The hubs handle pharma well. What India lacks is a chain that performs the same way in every city, at every handover and for every material.

That gap can be closed, but not by money alone. It needs standards that travel with the product, shared services that smaller firms can afford, and partnerships between manufacturers, airlines, airports and regulators. Baveja makes the same point. The countries that succeed in biopharma, he says, are those where innovation, infrastructure and logistics work together.

Three markers are worth watching: more international freighters shifting to Navi Mumbai, hiring for the CDSCO review cadre and accreditation of the trial sites. Each will show whether SHAKTI is moving from announcement to delivery.

The biopharma revolution has started. The supply chain will decide how far it goes.